Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 2

Conditions: Peritoneal Cavity Cancer; Ovarian Cancer

Treatments: Drug: docetaxel; Drug: carboplatin; Biological: pegfilgrastim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00217568

PSOC 1702

PSOC-1702

PSOC-IRB-4861

CDR0000441307 (Registry Identifier)

AVENTIS-PSOC-1702

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.

Full description

OBJECTIVES:

• Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
• Determine the response rates (complete and partial response) in patients treated with this regimen.
• Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.

After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer

  • Stage III or IV disease
  • No borderline tumors

• Measurable or evaluable disease

  • Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
  • Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)

• In first relapse

  • Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Platelet count ≥ 100,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Bilirubin normal

• Meets 1 of the following criteria:

  • SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
  • SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal

Renal

• Creatinine ≤ 2.0 mg/dL
• Creatinine clearance > 50 mL/min

Cardiovascular

• LVEF ≥ 50%
• No poorly controlled arrhythmia
• No unstable coronary artery disease or myocardial infarction within the past year

Other

• HIV negative
• No pre-existing peripheral neuropathy > grade 2
• No history of allergy to study drugs

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 weeks since prior radiotherapy and recovered

Surgery

• Recovered from recent prior surgery

Other

• No concurrent myelosuppressive therapy